Investigation of the Food Effect on the Pharmacokinetics of JT408T
- Conditions
- Improvement of neurological symptoms of Gaucher's disease
- Registration Number
- JPRN-jRCT2051210024
- Lead Sponsor
- Yutaka Shunichiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 16
1) Personally provided written voluntary informed consent to participate in the study
2) Japanese men aged >= 20 and < 35 years at the time of informed consent
3) BMI >= 18.5 and < 25.0 kg/m2 and Weight >=50.0kg <75.0kg at screening
4) Patients who can agree to the contraception from the start JT408T administration to the time of final observation. And patients who can agree not to donate sperm for the purpose of fertilization, etc.
1) Persons who have abnormal findings in medical examinations and various tests, and the investigator has determined that there is a clinical problem.
2)Persons with complications or medical history that are considered inappropriate for participation in this study. (Liver disorder, renal disorder, cardiovascular disease, endocrine system disease, metabolic disease, respiratory system disease, neurological disease, urinary system disease, immune system disease, psychiatric disease, etc.)
3)Persons who have or have a history of allergies to drugs or food, or who are suspected of having any of them
4)Persons who have been diagnosed with malignant tumors (including those who have a history within 5 years before obtaining consent)
5)Persons who have undergone surgical operations that are known to affect the gastrointestinal absorption of drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method